EU PV, Legislation, GVP, changes, Drug Safety

EU PV Legislation & GVP Modules: Challenges

At the 2014 World Drug Safety Congress Americas, Dr Janet Hormbrey, Merck Sharp and Dohme, gave a presentation on “EU PV Legislation & GVP Modules: Challenges”. Download and learn: GVP Implementation Upcoming Modules Implementation Challenges Module V – Risk Management Plans Module VII – Periodic Safety Update Report Module VIII – Post Authorisation Safety Studies Module IX – Signal Management …

New EU, Vigilance Practices, Legislation, Drug safety

New EU Good Vigilance Practices Legislation

At the 2014 World Drug Safety Congress Americas, Mariska Kooijmans, Biogen Idec, gave a presentation on “New EU Good Vigilance Practices Legislation.” Download and learn: Background and goals EU PV Legislation EU GVP Modules – major changes PRAC PV Quality Requirements Pharmacovigilance Systems Master File (PSMF) Biogen Idec approach to implementation Summary Download Presentation Found this interesting? Join us in …

Download: Audits and inspections since the new PV legislation – a personal reflection

Sue Rees, EU QPPV, Executive Director, Global Safety, Amgen gave a presentation at last year’s World Drug Safety Congress Europe entitled “Audits and inspections since the new PV legislation – a personal reflection”. Download the presentation to learn What has not changed? What has changed? How can you prepare for an inspection QPPV oversight Take home messages Download presentation For …

How effective due diligence can protect your business reputation and inform management decisions

    In the face of increasing international pressures, growth in high risk jurisdictions, more regulation and legislation, companies in the Pharmaceutical sector are increasingly exposed to huge reputational damage, often without even realising the danger. At Pharma Compliance 2013, Michael Harris, Head of Integrascreen Sales EMEA, Governance, Risk and Compliance, Thomson Reuters will be joining us to discuss how …

Download Ebook: Top 5 biggest challenges in Pharma compliance

The increasing number of transparency regulations in Pharma and anti-corruption & anti-bribery laws are beginning to resemble legislation in the United States. The risk of severe fines and a tarnished reputation means companies need to make sure they are managing risk and implementing a comprehensive compliance programme. But what are the key challenges faced by compliance professionals in pharma? From …

Why orphan drugs are a key part of pharma’s future?

Back in the 1980's when the Orphan Drug Act was created, legislators, government agencies and even industry weren't expecting that it would create a multi-billion dollar market where companies now fight fiercely for a share in this segment. It's also understood that the timing of the Act was very fortuitous as it was closely aligned with the beginning of US' …

New European pharmacovigilance legislation – what are pharma saying about it?

The new European pharmacovigilance legislation for human use – how is the industry responding to the changes and what are they expecting the impact will be on safety strategy and practical implications. We've been listening to the industry on this and its been great hearing what pharma has to shout about including their expectations, the good, the bad and the …